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Package Leaflet: Information for the Patient Tanatril 5Mg, 10 Mg & 20Mg Tablets Active Substance: Imidapril Read All of This

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Package Leaflet: Information for the Patient Tanatril 5Mg, 10 Mg & 20Mg Tablets Active Substance: Imidapril Read All of This Package leaflet: Information for the patient Tanatril 5mg, 10 mg & 20mg Tablets Active substance: Imidapril Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Tanatril is and what it is used for 2. What you need to know before you take Tanatril 3. How to take Tanatril 4. Possible side effects 5. How to store Tanatril 6. Contents of the pack and other information 1. What Tanatril is and what it is used for Tanatril is used to treat high blood pressure (hypertension). Tanatril is one of a group of medicines called ACE (angiotensin-converting enzyme) inhibitors. If you have high blood pressure, Tanatril works by widening blood vessels, so that blood passes through them more easily. Since blood pressure depends on the diameter of blood vessels, your blood pressure will be lowered by Tanatril. Also, it will be easier for your heart to pump blood through the vessels around the body. 2. What you need to know before you take Tanatril Do not take Tanatril • if you are allergic to imidapril, other ACE inhibitors or any of the other ingredients of this medicine (listed in section 6) • if you have suffered from angioedema (a serious allergic reaction that causes swelling of the hands, feet or ankles, face, lips, tongue and throat and may lead to difficulty with swallowing or breathing) after taking a similar medicine to imidapril (ACE inhibitor) • if you or a close family member has suffered from angioedema before • if you have any problem with your kidneys or if you need to be dialysed • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren • if you are more than 3months pregnant. (It is also better to avoid Tanatril in early pregnancy - see pregnancy section). If any of these situations applies to you, do not take Tanatril. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Tanatril • if you are dehydrated due to treatment with diuretics (‘water tablets’), dialysis, a low salt diet or because you have had strong and prolonged vomiting or diarrhoea. You are more likely to suffer from a very large drop in your blood pressure (hypotension) when you start to take tablets and may feel faint or light-headed • if you have been told that you have a problem with your heart. Ask your doctor, if you are not sure if this applies to you • if you have any liver problems • if you suffer from diabetes • if you are taking potassium supplements or potassium-containing salt substitutes • if you are being treated with allopurinol to prevent gout, kidney stones, or high levels of uric acid • if you are being treated with procainamide to correct irregular heartbeats and to slow a rapid heart rate • if you are taking a lithium medicine used for the treatment of mania or depression • if you are allergic to insect bites and undergo a desensitisation treatment • if you receive a treatment for your immune system, for example after a transplant • if you have had a recent kidney transplant • if you are having a certain treatment called ‘LDL apheresis’ to reduce cholesterol-levels in your blood • if you are suffering from a condition called ‘cerebrovascular disease’ (narrowing of the blood vessels in the brain) • if you have a disease known as ‘collagen vascular disease’, such as rheumatoid arthritis • if you are undergoing any surgery or receive anaesthetics, tell your doctor or dentist • if your blood pressure is not sufficiently lowered. Medicines of this type seem to be less effective in persons with black skin • if you suffer from sudden swelling of the lips and face, tongue and throat, neck, possibly also hands and feet, difficulty to swallow or to breathe, hives or hoarseness (‘angioedema’). This may occur at any time during the treatment. Persons with black skin may have a higher risk of suffering from this condition. If you develop such symptoms you should let your doctor know immediately. • if you are taking any of the following medicines used to treat high blood pressure: - an angiotensin II receptor blocker (ARB) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems. - aliskiren. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also information under the heading Do not take Tanatril You must tell your doctor if you think you are (or might become) pregnant. Tanatril is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section). Children and adolescents Tanatril Tablets are not suitable for use in children. While taking Tanatril If you develop any of the following symptoms you should let your doctor know immediately: • You feel dizzy after your first dose. A few people react to their first dose or when their dose is increased by feeling dizzy, weak, faint or sick. • High temperature, sore throat or mouth ulcers (these may be symptoms of infection caused by lowering of the number of white blood cells). • Yellowing of the skin and whites of eyes (jaundice) that may be sign of liver disease. You will need medical check-ups whilst you are taking Tanatril, which may involve regular blood tests. You will be closely monitored when you start your treatment or if your dose is changed. Your doctor will advise you how often you will need to see him/her. Other medicines and Tanatril Tell your doctor if you are taking, have recently taken or might take anyother medicines. Medicines: Used for instance in the treatment of: Potassium sparing diuretics (water tablets) heart failure, liver disease, certain kidney (spironolactone, triamterene or amiloride) diseases Potassium tablets or liquids or salt substitutes low blood levels of potassium containing potassium Non-potassium sparing diuretics (water high blood pressure, oedema (swelling of the tablets) (thiazide, furosemide) fingers, legs, toes and face) Lithium mania or depression Non-steroidal anti-inflammatory drugs muscle pain, stiffness and inflammation (NSAIDs) (indomethacin, diflunisal or (arthritis) diclofenac, celecoxib or valdecoxib and aspirin) Injectable gold pain, stiffness and inflammation (arthritis) Antihypertensives (such as methyldopa, high blood pressure clonidine, moxonidine) Nitroglycerin or other nitrates heart disease, chest pain Antidiabetics (insulin), oral antidiabetics diabetes (metformin, pioglitazone) Thrombolytics (clopidogrel); beta blockers heart attack, high blood pressure (bisoprolol, metoprolol) Tricyclic antidepressants (such as depression and mental disorders amitriptyline); neuroleptics (such as phenothiazines or butyrophenones) Rifampicin tuberculosis (known as TB), and other mycobacterial infections Antacids (ranitidine, pantoprazole) heartburn, sore stomach and acid indigestion Sympathomimetics (medicines that stimulate low blood pressure, shock, heart failure, the central nervous system) such as ephedrine, asthma or allergies salbutamol (which may also be found in some cough/cold remedies) and noradrenaline or adrenaline Allopurinol prevention of gout, treatment of kidney stones or high levels of uric acid Procainamide irregular heartbeats and to slow a rapid heart rate Anaesthetics (agents suppressing nerve used when you undergo surgery, even at the impulses) dentist Immunosuppressants (medicines that suppress used e.g. when you have had a recent organ the body’s immune response) transplant Your doctor may need to change your dose and/or to take other precautions: If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings Do not take Tanatril and Warnings and precautions Pregnancy You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Tanatril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Tanatril. Tanatril is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. Breast-feeding Tell your doctor if you are breast-feeding or about to start breast-feeding. Tanatril is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is new-born, or was born prematurely. Driving and usingmachines Tanatril may make you feel dizzy or sleepy. Do not drive or operate machinery until you know if Tanatril affects you. Tanatril contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. 3. How to take Tanatril Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist, if you are not sure. Instructions: Take the tablets about 15minutes before your meals Swallow the tablets with plenty of water Take your tablets at the same time each day The tablet can be divided into equal doses Dosage (adults) The usual starting dose is 5mg per day. After 3 weeks your blood pressure needs to be measured again to check the results.
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